Overview

ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling

Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in hypertensive patients.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Amlodipine
Hydrochlorothiazide
Losartan
Criteria
Inclusion Criteria:

- Patient with hypertension

- Confirmed concentric left ventricular hypertrophy:

- LVMI > 49.2 g/m2.7 for men and >46.7 g/m2.7 for women

- Relative wall thickness > 0.42

Exclusion Criteria:

- Sever or secondary HTN

- LV ejection fraction of <40%

- Patient with compelling indication to ACEIs or ARBs or BB

- History of myocardial infarction, coronary artery bypass surgery, PTC intervention,
TIA or stroke within 6 months of study entry

- History of collagenopathies, osteopathy

- eGFR <30 ml/min/1,73 m2, serum potassium ≥5,2 mEq/L

- Morbid obesity (BMI ≥ 42 kg/m2

- Other protocol-defined inclusion/exclusion criteria may apply